Testing the Elevation as Sleep Apnea Treatment (TEST)

Pulmonar

Status: Completed

Conditions: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep

Treatments: Behavioral: Head of bed elevation

Study type: Interventional

Funder types: Other

Identifiers

NCT02088723

Apnea-PULMONAR-1

Details and patient eligibility

About

The purpose of this study is to determine if the elevation of the head of the bed in patients with obstructive sleep apnea can decrease the apnea-hypopnea index. First the investigators will do a standard polysomnography and see if the patients are included analysing the criteria like apnea-hypopnea index equal or more than 5. Within 2 weeks the patient will do the second polysomnography but this will be with a elevation of the head of the bed (15 cm of elevation of the bed doing a inclination). Then the investigators will compare the data of apnea-hypopnea index in the standard polysomnography versus the index with the elevation of the head of the bed.

Full description

There are many researches that demonstrate that the position of the patient modified the apnea-hypopnea index(IAH). In supine position the IAH will increase comparing with lateral position during th sleep. However few studies were done with the elevation of the head of the bed.

First the investigators will do a standard polysomnography and see if the patients are included analysing the criteria like apnea-hypopnea index equal or more than 5. Within 2 weeks the patient will do the second polysomnography but this will be with a elevation of the head of the bed (15 cm of elevation of the bed doing a inclination). Then the investigators will compare the data of apnea-hypopnea index in the standard polysomnography versus the index with the elevation of the head of the bed.The main outcome will be to analyze the apnea hypopnea index comparing standard polysomnography (sPSG) with elevated polysomnography (ePSG).

Enrollment: 52 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Berlin questionnaire high risk
• Epworth score > 9
• Obstructive Sleep Apnea with an index ≥ 5 events/hour on the polysomnography (The American Academy of Sleep Medicine Manual for the Scoring of Sleep and Associated Events: rules,terminology and technical specifications. American Academy of Sleep Medicine, 2012)

Exclusion criteria

• younger than 18 years and older than 80 years
• BMI more than 40 Kg/m2
• heart failure
• renal failure
• uncontrolled respiratory disease
• uncontrolled neurological disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

head of bed elevation

Experimental group

Description:

Compare the apnea hypopnea index with the patient in standard polysomnography and in elevated polysomnography (head of bed elevation)

Treatment:

Behavioral: Head of bed elevation